Full Press Release Details
Reports First Quarter 2022 Financial Results
Calif., May 11, 2022 - Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient
outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, today reports financial
results for the first quarter 2022, ended March 31, 2022.
Quarter and Recent Highlights:
| Reported total revenue of $1.4 million in the first quarter of 2022, compared with $1.1 million in the first quarter of 2021. | ||
| Launched our CLIA validated lab test for TheraSure TM Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test which has shown to successfully achieve an early indication of rejection episodes in organ transplant patients using a digital polymerase chain reaction (dPCR) technique. | ||
| Closed a platform partnership with Thermo Fisher to gain access to Ex-US channel for the Determa product line | ||
| Completed Irvine facility build out and installed Genexus instruments to begin DetermaIO IVD Kit process. | ||
| Completed an equity financing by raising $32.8 million in common stock to strengthen the balance sheet and further support our product portfolio. |
continued to make solid progress in the first quarter, delivering 73% year over year growth in DetermaRx sample volumes and successfully
onboarding new physicians and accounts. We also successfully completed an underwritten financing to strengthen our balance sheet and
fuel our upcoming product launch efforts," said Ron Andrews, President and Chief Executive Officer of Oncocyte. "Looking
ahead, we remain enthusiastic about our upcoming DetermaIO data releases at ASCO in early June and the continued rapid progress
we have made to launch our transplant business as we announced last week. We also remain on track to submit three additional oncology
tests, DetermaIO , DetermaTx and DetermaCNI , for reimbursement over the next 12-18 months. I appreciate the continued
support of our shareholders and look forward to updating you as we execute on our strategic plans."
Quarter 2022 Financial Results
revenue was $1.4 million for the first quarter of 2022, compared to $1.1 million for the prior quarter. First quarter revenues associated
with DetermaRx were $1.0 million, up $0.2 million sequentially, and up $0.4 million year over year. Operating expenses for the first
quarter 2022 were $9.4 million, compared to $11.4 million, a decrease of $2.0 million from the same period in the prior year. Research
and Development expense for the first quarter 2022 was $5.1 million, an increase of $1.8 million from the same period a year ago. The
increase in R&D expense was related to increased headcount in support of clinical trials in oncology and transplant. General and
Administrative expense for the first quarter of 2022 was $5.7 million, an increase of $0.9 million for the same period in 2021, due primarily
due to an increase in personnel and related expenses. Sales and Marketing expense in the quarter was $3.2 million, an increase of $1.0
million year over year, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities related
to the transplant business, as well as support the commercialization efforts within oncology.
loss was $10.3 million for the first quarter of 2022 and net loss per share was $0.11 on a weighted-average basic and diluted share count
of 92.2 million, compared to a net loss of $3.9 million and a net loss per share of $0.05 on a weighted-average basic and diluted share
count of 82.1 million in the same period of the prior year.
cash equivalents, restricted cash and marketable securities were $22.7 million as of March 31, 2022.
and Conference Call Information
will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 11, 2022 at 1:30
p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or
(201) 493-6779 for international callers, using conference ID: 13729461. The live webinar can be accessed at https://investors.oncocyte.com.
is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical
decisions throughout the patient care journey.
Company, through its proprietary tests and pharmaceutical services business, aims to help save lives by accelerating the diagnosis of
cancer and advancing cancer care. The Company's tests are designed to help provide clarity and confidence to physicians and their
patients at every stage post-diagnosis treatment. DetermaRx identifies early-stage lung cancer patients who are at high risk for
cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO , a gene expression test currently used as a research-use
only tool, assesses the tumor microenvironment to predict response to immunotherapies. The Company's pipeline of tests in development
also includes DetermaTx , which will assess mutational status of a tumor, blood-based test DetermaCNI , which can monitor
cancer patients for recurrence of disease, long-term recurrence monitoring test DetermaMx , and blood-based solid organ transplantation
monitoring test TheraSureTM. In addition, Oncocyte's pharmaceutical services provide companies that are developing new
cancer treatments a full suite of molecular testing services to support the drug development process.
DetermaIO , DetermaTx , DetermaCNI , DetermaMx and TheraSure are trademarks of Oncocyte Corporation.
statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes,"
"plans," "anticipates," "expects," "estimates," "may," and similar expressions)
are forward-looking statements. These statements include those pertaining to, among other things, TheraSure, such as the expectation
of expedited validation of TheraSure for kidney and heart transplants and of conversion of the lab workflow into a kit, and other statements
about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks
and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries' financial and
operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results
of clinical trials or regulatory approvals, the capacity of Oncocyte's third-party supplied blood sample analytic system to provide
consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain
future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect
to licensed or acquired technology and products, the need to obtain third party reimbursement for patients' use of any diagnostic
tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the
potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting
and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential
failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated
in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect
the business of Oncocyte, particularly those mentioned in the "Risk Factors" and other cautionary statements found in Oncocyte's
Securities and Exchange Commission (SEC) filings, which are available from the SEC's website. You are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to
update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required
Westwicke Healthcare PR
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 20,412 | $ | 35,605 | ||||
| Accounts receivable | 2,122 | 1,437 | ||||||
| Marketable equity securities | 574 | 904 | ||||||
| Prepaid expenses and other current assets | 1,515 | 1,197 | ||||||
| Total current assets | 24,623 | 39,143 | ||||||
| NONCURRENT ASSETS | ||||||||
| Right-of-use and financing lease assets, net | 2,636 | 2,779 | ||||||
| Machinery and equipment, net, and construction in progress | 8,015 | 5,748 | ||||||
| Goodwill | 18,684 | 18,684 | ||||||
| Intangible assets, net | 90,317 | 91,245 | ||||||
| Restricted cash | 1,700 | 1,700 | ||||||
| Other noncurrent assets | 298 | 264 | ||||||
| TOTAL ASSETS | $ | 146,273 | $ | 159,563 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 2,584 | $ | 2,447 | ||||
| Accrued compensation | 3,380 | 3,376 | ||||||
| Accrued expenses and other current liabilities | 3,256 | 2,425 | ||||||
| Accrued severance from acquisition, current | 2,316 | 2,352 | ||||||
| Accrued liabilities from acquisition, current | 624 | 1,388 | ||||||
| Loans payable, net of deferred financing costs, current | 945 | 1,313 | ||||||
| Right-of-use and financing lease liabilities, current | 850 | 819 | ||||||
| Total current liabilities | 13,955 | 14,120 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Right-of-use and financing lease liabilities | 3,326 | 3,545 | ||||||
| Contingent consideration liabilities, noncurrent | 72,025 | 76,681 | ||||||
| TOTAL LIABILITIES | 89,306 | 94,346 | ||||||
| Commitments and contingencies | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Preferred stock, no par value, 5,000 shares authorized; no shares issued and outstanding | - | - | ||||||
| Common stock, no par value, 230,000 shares authorized; 92,247 and 92,232 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 254,994 | 252,954 | ||||||
| Accumulated other comprehensive loss | 38 | 37 | ||||||
| Accumulated deficit | (198,065 | ) | (187,774 | ) | ||||
| Total shareholders' equity | 56,967 | 65,217 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 146,273 | $ | 159,563 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Net revenue | $ | 1,424 | $ | 1,124 | ||||
| Cost of revenues | 1,021 | 738 | ||||||
| Cost of revenues - amortization of acquired intangibles | 936 | 307 | ||||||
| Gross profit | (533 | ) | 79 | |||||
| Operating expenses: | ||||||||
| Research and development | 5,128 | 3,361 | ||||||
| Sales and marketing | 3,237 | 2,254 | ||||||
| General and administrative | 5,653 | 4,764 | ||||||
| Change in fair value of contingent consideration | (4,656 | ) | 1,060 | |||||
| Total operating expenses | 9,362 | 11,439 | ||||||
| Loss from operations | (9,895 | ) | (11,360 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense, net | (30 | ) | (68 | ) | ||||
| Unrealized gain (loss) on marketable equity securities | (330 | ) | 213 | |||||
| Pro rata loss from equity method investment in Razor | - | (270 | ) | |||||
| Other income (expense), net | (36 | ) | 2 | |||||
| Total other income (expenses), net | (396 | ) | (123 | ) | ||||
| LOSS BEFORE INCOME TAXES | (10,291 | ) | (11,483 | ) | ||||
| Income tax benefit | - | 7,564 | ||||||
| NET LOSS | $ | (10,291 | ) | $ | (3,919 | ) | ||
| Net loss per share: basic and diluted | $ | (0.11 | ) | $ | (0.05 | ) | ||
| Weighted average shares outstanding: basic and diluted | 92,243 | 82,123 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (10,291 | ) | $ | (3,919 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | 287 | 121 | ||||||
| Amortization of intangible assets | 928 | 307 | ||||||
| Pro rata loss from equity method investment in Razor | - | 270 | ||||||
| Stock-based compensation | 2,010 | 1,290 | ||||||
| Unrealized gain (loss) on marketable equity securities | 330 | (213 | ) | |||||
| Amortization of debt issuance costs | 7 | 19 | ||||||
| Change in fair value of contingent consideration | (4,656 | ) | 1,060 | |||||
| Deferred income tax benefit | - | (7,564 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (685 | ) | (499 | ) | ||||
| Lease liabilities | (35 | ) | 25 | |||||
| Prepaid expenses and other assets | (351 | ) | (1,137 | ) | ||||
| Accounts payable and accrued liabilities | (21 | ) | 405 | |||||
| Accrued severance and liabilities from Chronix Biomedical acquisition | (800 | ) | - | |||||
| Net cash used in operating activities | (13,277 | ) | (9,835 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Acquisition of Insight Genetics, net of cash acquired | - | (607 | ) | |||||
| Acquisition of Razor Genomics asset, net of cash acquired | - | (6,648 | ) | |||||
| Acquisition of Chronix Biomedical, net of cash acquired | - | (175 | ) | |||||
| Construction in progress and purchases of furniture and equipment | (1,561 | ) | (842 | ) | ||||
| Net cash used in investing activities | (1,561 | ) | (8,272 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from exercise of stock options | - | 348 | ||||||
| Proceeds from sale of common shares | - | 65,262 | ||||||
| Financing costs to issue common shares | - | (2,676 | ) | |||||
| Proceeds from sale of common shares under at-the-market transactions | 31 | 6,754 | ||||||
| Financing costs for at-the-market sales | (1 | ) | (203 | ) | ||||
| Proceeds from exercise of warrants | - | 802 | ||||||
| Repayment of loan payable | (375 | ) | (375 | ) | ||||
| Repayment of financing lease obligations | (10 | ) | (41 | ) | ||||
| Net cash provided by (used in) financing activities | (355 | ) | 69,871 | |||||
| NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (15,193 | ) | 51,764 | |||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING | 37,305 | 8,843 | ||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING | $ | 22,112 | $ | 60,607 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||||||||
| Cash paid for interest | $ | 13 | $ | 44 | ||||
| SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING AND INVESTING ACTIVITIES | ||||||||
| Common stock issued for acquisition of Razor Genomics asset | $ | - | $ | 5,756 | ||||
| Deferred tax liability generated from the acquisition of Razor Genomics asset | - | 7,564 | ||||||
| Construction in progress, machinery and equipment purchases included in accounts payable, accrued liabilities and landlord liability | 993 | 139 |
of Non-GAAP Financial Measure
Loss from Operations
| For the Three Months Ended | ||||||||||||
| March 31, | December 31, | March 31, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| (unaudited) | (unaudited) | (unaudited) | ||||||||||
| GAAP loss from operations - as reported | $ | (9,895 | ) | $ | (35,680 | ) | $ | (11,360 | ) | |||
| Stock-based compensation expense | 2,010 | 1,706 | 1,290 | |||||||||
| Change in fair value of contingent consideration | (4,656 | ) | 25,006 | 1,060 | ||||||||
| Severance charge | - | 255 | - | |||||||||
| Depreciation and amortization expense | 1,216 | 1,251 | 428 | |||||||||
| Non-GAAP loss from operations, as adjusted | $ | (11,325 | ) | $ | (7,462 | ) | $ | (8,582 | ) |